Inspiratory Muscle Activation Pattern Analysis in Assisting Precision in Inspiratory Muscle Training in Patients With Chronic Respiratory Disease

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03880630
Collaborator
(none)
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Study Details

Study Description

Brief Summary

Background & Objective: Inspiratory muscle training (IMT) is known to improve strength and endurance of inspiratory muscles. However, clinical beneficial effects of IMT for patients with chronic respiratory disease remain inconclusive.

The purposes of the study are to investigate in patients with chronic respiratory disease:

(Year 1) main (diaphragm) and accessory inspiratory muscle (sternocleidomastoid muscle) activation pattern during various IMT loading using group-based trajectory modeling (GBTM); and (Year 2) effectiveness of individualized IMT program (based on results of Year 1) on clinical outcomes. Methods: (Year 1) Patients with chronic respiratory disease with inspiratory muscle weakness will be recruited for the study. Patients will perform 3 inspiratory loading tests (15%, 30%, and 50% of maximum inspiratory pressures) on 3 separate days with the sequence will be randomized. Surface electromyography (EMG) of diaphragm and sternocleidomastoid muscle will be used to use inspiratory muscle activation during various conditions. Other outcomes include maximum inspiratory pressure, and functional exercise capacity will be measured. Inspiratory muscle activation will be used for GBTM analysis. Patient will then be trained with individualized IMT program based on the GBTM analysis input form results of Year 1.

Condition or Disease Intervention/Treatment Phase
  • Other: Inspiratory muscle training
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
1 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Inspiratory Muscle Activation Pattern Analysis in Assisting Precision in Inspiratory Muscle Training in Patients With Chronic Respiratory Disease
Actual Study Start Date :
Oct 6, 2020
Actual Primary Completion Date :
Dec 31, 2020
Actual Study Completion Date :
Dec 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Chronic respiratory disease

Patients with chronic respiratory disease with inspiratory muscle weakness will be recruited for the study

Other: Inspiratory muscle training
Patients will perform 3 inspiratory loading tests (15%, 30%, and 50% of maximum inspiratory pressures) on 3 separate days with the sequence will be randomized. Patient will then be trained with individualized IMT program based on the results of 3 inspiratory loading tests.

Outcome Measures

Primary Outcome Measures

  1. Diaphragm and Sternocleidomastoid muscle activation [through the completion of the inspiratory loading tests condition; it would take about 3 minutes]

    Root mean square values during different conditions

  2. The mean median frequency of diaphragm and sternocleidomastoid muscle [In five minute after the completion of the loaded inspiratory muscle test condition]

    The power spectrum is divided into two equal areas of the frequency value by median frequency to exam muscle fatigability

  3. Pulmonary function [About five minutes to complete]

    Forced expiratory volume in one second, forced vital capacity, residual volume, total lung capacity

  4. Maximal inspiratory pressure test [About three minutes to complete]

    Maximal inspiratory pressure

  5. Functional exercise capacity using the six-minute walk test [The six-minute walk test needs six minute to complete the test]

    The six-minute walk test is commonly performed to evaluate functional exercise capacity. The six-minute walk test was performed according to the guidelines, and the distance walked in the test presented as functional exercise capacity

  6. Heart rate [The six-minute walk test needs six minute to complete the test]

    Heart rate is measured at rest, during six-minute walk test

  7. Blood pressure [Before and immediately after the six-minute walk test;it takes less than one minute to measure blood pressure]

    systolic and diastolic pressure are measured at rest, after six-minute walk test

  8. Perceived dyspnea [It takes less than one minute to evaluate perceived dyspnea]

    Rating of perceived dyspnea is measured by using Borg scale at rest, during six-minute walk test, inspiratory loading tests. The most widely used tool is the "Borg scale", with rating ranges from 0 (nothing at all) to 10 (extremely dyspnea).

  9. Oxygen saturation [The six-minute walk test needs six minute to complete the test; through the completion of the inspiratory loading tests condition; it would take about 3 minutes]

    Oxygen saturation is continuously monitored by pulse oximetry throughout six-minute walk test, inspiratory loading tests

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • age > 20 years old

  • has been diagnosis of chronic obstructive pulmonary disease with stable clinical condition with no infection or acute exacerbation in the previous four weeks

  • can cooperate with the measurements of this study

Exclusion Criteria:
  • any clinical diagnosis that will influence the measurement, including any history of

  • neuromyopathy

  • angina, acute myocardial infarction in the previous one month

  • pregnancy

  • participated in inspiratory muscle training program in the previous three months

  • any psychiatric or cognitive disorders, for example: Mini-Mental State Examination (MMSE) < 24, that will disturb the communication and cooperation of the study

Contacts and Locations

Locations

Site City State Country Postal Code
1 School & Graduate Institute of Physical Therapy, College of Medicine, NTU Taipei Taiwan 100

Sponsors and Collaborators

  • National Taiwan University Hospital

Investigators

  • Study Chair: Li-Ying Wang, Phd, National Taiwan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT03880630
Other Study ID Numbers:
  • 201812172RIND
First Posted:
Mar 19, 2019
Last Update Posted:
Mar 18, 2021
Last Verified:
Mar 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 18, 2021